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A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 37 → 48 participants
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer. 1. What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ? 2. What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed. Participates will 1. The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks). 2. Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy. 3. Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy. 4. Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent. 5. Pathological assessment
Trial Details
NCT Number NCT07854964
Lead Sponsor Tang-Du Hospital
Conditions
(from sponsor)		 Locally Advanced Rectal Cancer
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov